– Recent safety and efficacy data in both ulcerative colitis and pouchitis continue to support the potential of MH002 in indications characterized by mucosal damage and inflammation.
Ghent, Belgium, May 15, 2024–(BUSINESS WIRE)–MRM Health NV is a clinical-stage biopharmaceutical company developing innovative treatments for inflammatory, central nervous system, and metabolic diseases. announced today that it will release positive data on its flagship asset, MH002. 2 during the 2024 Digestive Disease Week® (DDW) Conference on Live Microbial Consortium Therapies for Inflammatory Bowel Disease, May 18-21, 2024 at the Walter E. Washington Convention Center in Washington, DC. This was announced in an oral presentation.
Late breaker presentation details
Session Title: IMIBD Late Breaker and IBD Innovation
Presentation Title: Safety and Efficacy of Optimized Live Biotherapy Product MH002 for the Treatment of Mild to Moderate Ulcerative Colitis: First-Disease, Double-Blind, Randomized Clinical Trial
Presenter: Dr. Séverine Vermere, Principal Investigator and Scientific Advisor, MRM Health
Date and Time: Sunday, May 19, 2024, 3:15pm – 3:30pm EDT
Location: Ballroom B
Excellent presentation poster details
Session title: Microbial therapy for gastrointestinal diseases
Session sponsor: AGA
Presentation Title: MH002, a live biotherapeutic product optimized for the treatment of inflammatory bowel disease, has a mechanism of action related to gut dysbiosis, mucosal integrity, and restoration of immune homeostasis
Poster number: Mo1919
Speaker: Dr. Sam Possemiers, CEO, MRM Health
Date and Time: Monday, May 20, 2024, 12:30pm – 1:30pm EDT
This poster was selected by DDW as an “Outstanding Poster” which recognizes the top 10% of all AGA abstracts selected for poster presentation.
The main findings presented are:
– The primary endpoint of a placebo-controlled Phase 2a study in patients with mild to moderate ulcerative colitis was to demonstrate an excellent safety profile and tolerability at a fixed dose of 400 mg per day over 16 weeks. demonstrated and achieved.
– Initial efficacy on disease activity was demonstrated on clinically relevant parameters including a 12% improvement in Mayo Endoscopic Severity (MES) score (p=0.05, one-sided Wilcoxon rank sum test), whereas placebo % worsened. Stool consistency improved significantly in the MH002 treatment group from week 2 (p = 0.006; one-tailed Student's t-test). At the end of the 8-week period, 18% of the subjects achieved clinical remission, compared with 0% in the placebo group (per-protocol analysis). In contrast to previous trials using other live biological therapies at the University of California, this study was successfully conducted without vancomycin preconditioning.
– At a mechanistic level, an anti-inflammatory effect was demonstrated, with a median reduction in fecal calprotectin (a clinically relevant marker of intestinal inflammation) by 42% at week 8, compared to an 18% reduction with placebo. Additionally, microbiome recovery occurred in parallel with clinical efficacy. And differential gene expression analysis showed downregulation of genes involved in inflammation. These findings are consistent with the mechanism of action of MH002 and were associated with dysbiosis of the gut microbiota, mucosal integrity, and restoration of immune homeostasis.
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About MH002
MH002 is currently the most advanced rationally designed live microbial consortium therapy in inflammatory bowel disease, with proven safety and efficacy in Phase 2a trials in both ulcerative colitis and pouchitis . Developed through MRM Health's proprietary CORAL® technology, it is a well-characterized, safe, well-characterized drug that has been selected and optimized to address key disease-causing mechanisms with enhanced efficacy, resilience, and engraftment. It consists of six commensal strains. MRM Health's revolutionary scalable and standardized cGMP manufacturing platform enables complete consortium manufacturing as a single drug substance. This capability of CORAL® will enable the scalable and cost-effective manufacturing of fully optimized consortia in a single process, and is expected to deliver both significant regulatory and patient compliance benefits. will be done.
About MRM Health
MRM Health is a clinical-stage biotechnology developing innovative treatments for inflammatory, central nervous system, and metabolic diseases. Our most advanced program, MH002, is gearing up for pivotal clinical development in ulcerative colitis and/or the rare disease indication pouchitis. MRM Health leverages its unique and disruptive CORAL® technology platform to design microbiome-based biotherapies based on specific combinations of 5-10 living gut bacteria that target diseases. Optimize them for faster onset of action and increased potency and robustness. A key differentiator is that these consortia can be manufactured as a single drug substance in a single process that is standardized, scalable, and cost-effective. In addition to its inflammatory bowel disease programs, MRM Health continues preclinical programs in Parkinson's disease and spondyloarthritis, and programs in partnership with IFF in type 2 diabetes and NAFLD.
For more information, please visit our website www.mrmhealth.com.
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contact address
For more information, please contact us below.
MRM Health
Dr. Sam Posemiers – CEO
Christiane Verhagen – CFO
Phone number: +32.9.277.08.50
info@mrmhealth.com
Rigorous investor relations activities
Stephanie Asher
Stephanie.ascher@sternir.com
+1 212-362-1200
